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InHealth Technologies - Blom-Singer®

FDA UDI

Class II (US FDA UDI)

by Freudenberg Medical, Llc

Identity

Trade Name
InHealth Technologies; Blom-Singer® FDA UDI
Generic Name
Tracheostomy tube speech valve FDA UDI
Device Name
Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 12mm length FDA UDI
Model / Reference
TP 2012 FDA UDI
Description
Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 12mm length FDA UDI

Identifiers

Primary DI / UDI-DI
00848253002606 FDA UDI
FDA Product Code
EWL FDA UDI
GMDN Term
Tracheostomy tube speech valve FDA UDI
Models / Variants
InHealth Technologies FDA UDI
Blom-Singer® FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tracheostomy tube speech valveTracheoesophageal speech valve guidewire

InHealth Technologies - Blom-Singer® by Freudenberg Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Tracheoesophageal speech valve guidewire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Freudenberg Medical, Llc

Sources (1)

  • FDA UDI 29e6e6c0-aa68-4e7a-857a-eff786e3780f 34 fields · synced Sep 18, 2026